Hyqvia: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is HyQvia used for?

HyQvia is used to treat adults and children with primary immunodeficiency diseases (PI), and secondary immunodeficiency diseases (SI).

HyQvia is used in adult patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) after having their CIDP symptoms stabilized with previous intravenous immunoglobulin (IVIG) treatments. CIDP is characterised by chronic inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms. It is believed that the body’s own defense system attacks the peripheral nerves and causes nerve damage and inflammation. Immunoglobulins present in HyQvia are thought to help protect the nerves from being damaged by the immune system.

How does HyQvia work?

The recombinant human hyaluronidase is a protein that makes it easier for the immunoglobulins to be infused (dripped) under the skin and to reach your blood system.

The vial of immunoglobulins has been prepared from the blood of healthy people. Immunoglobulins are produced by the human body’s immune system. They help your body to fight infections caused by bacteria and viruses or maintain the balance in your immune system (referred to as immunomodulation). The medicine works in the same way as the immunoglobulins naturally present in the blood.

What are the ingredients in HyQvia?

Medicinal ingredients: Human normal immunoglobulin, 10%

Non-medicinal ingredients: glycine, water for injection

Recombinant human hyaluronidase: calcium chloride dihydrate, edetate disodium dihydrate, human albumin, sodium chloride, sodium hydroxide, sodium phosphate dibasic dihydrate

HyQvia comes in the following dosage forms:

HyQvia contains two solutions for subcutaneous (SC) infusion under the skin. It is supplied as a package containing one vial of human normal immunoglobulin 10% and one vial of recombinant human hyaluronidase. HyQvia is available in 25, 50, 100, 200 and 300 mL vial sizes of immunoglobulin, each supplied with a corresponding vial of hyaluronidase.

Do not use HyQvia if:

• you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase or any

  of the other ingredients of this medicine (see What are the ingredients in HyQvia?).

• if you have antibodies against immunoglobulin A (IgA) in your blood. This may occur if you have IgA deficiency. Since HyQvia contains trace amounts of IgA, you might have an allergic

  reaction.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HyQvia. Talk about any health conditions or problems you may have, including if you:

• Have or had any kidney, liver, or heart problems or history of blood clots
• Have an IgA deficiency, have antibodies to IgA
• Have a history of severe allergic reactions to IgG antibodies or other blood products

• Are pregnant, trying to become pregnant or are breast feeding.

• Have high blood pressure

Other warnings you should know about:

• Do not infuse HyQvia into or around an infected or red swollen area on your skin because it may cause the infection to spread.

• You may experience side effects (for example dizziness or nausea) during treatment with HyQvia that might affect the ability to drive and use machines. If this happens, you should wait until the reactions have disappeared before driving a vehicle or using machinery.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with HyQvia:

• Vaccinations: HyQvia may reduce the effect of some vaccines such as measles, rubella, mumps and chicken pox. Before you get any vaccines, tell your healthcare provider that you take HyQvia.
• Effects on blood tests: HyQvia contains many different antibodies, some of which can affect blood tests (serological tests). Tell your doctor about your treatment with HyQvia before any blood test.

How to take HyQvia:

• Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Also, see the “Detailed Instructions for Use” provided below.
• HyQvia has to be infused under the skin (subcutaneous administration). Do not infuse HyQvia into your veins (intravenously) nor into muscle (intramuscularly).
• Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained.
• You should be trained on how to infuse the drug, how to use the pump or syringe driver, recording your treatment in your treatment diary, recognizing side effects and what to do about them.
• You and your doctor will decide if you can use HyQvia at home. Do not begin treatment with HyQvia at home until you have received complete instructions.
• You will take the hyaluronidase first. Make sure you infused the entire vial of hyaluronidase, even if you will not use up the entire vial of immunoglobulin. Then, within 10 minutes, you will take the immunoglobulin through an infusion pump. You must carefully follow your doctor’s instructions regarding the dose, infusion speed and schedule for infusing HyQvia so that your treatment works for you.
• Your doctor may perform blood tests regularly to check your IgG level and adjust your dosage.

Usual dose:

Primary and Secondary Immunodeficiency

Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment. In the beginning you will receive one quarter of this dose at 1 week intervals. This will be increased step-wise to larger doses at 3- to 4-week intervals with the next infusions. Sometimes your doctor may recommend that larger doses are split and given at two or three sites at once. Your doctor may also adjust your dose depending on your response to treatment.

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment. In the beginning you will receive one quarter of this dose at 1 week intervals. This will be increased step-wise to larger doses at 2- to 4-week intervals with the next infusions. Sometimes your doctor may recommend that larger doses are split and given at two or three sites at once. Your doctor may also adjust your dose depending on your response to treatment.

Overdose:

Missed Dose:

Do not infuse a double dose of HyQvia to make up for a missed dose. If you think that you have missed a dose speak to your doctor as soon as possible.

What are possible side effects from using HyQvia?

These are not all the possible side effects you may have when taking HyQvia. If you experience any side effects not listed here, tell your healthcare professional.

After HyQvia infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused.

The following local reactions may occur at the site of infusion and generally go away in a few hours: mild or moderate pain, redness, swelling, itching.

Local reactions are less likely after the first few infusions.

The most likely side effects of HyQvia, that occurred at rates of 5% or higher, are: headache, fatigue, nausea, fever, increase blood pressure, increased levels of enzymes made by your pancreas, abdominal pain, back pain, and pain in arms or legs.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Keep out of reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). You can take the product out of the refrigerator and store it at a temperature up to 25°C for 3 months. Do not use the product after the expiry date shown on the vial and carton even if the 3 month period is not over. Do not freeze. Do not shake.

Keep the vials in the outer carton in order to protect from light.

Do not use this medicine if the solutions are cloudy or have particles or deposits. After opening, dispose of any unused solutions in the vials.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Detailed Instructions for Use are provided in the section below.

1. Remove HyQvia from the box: • Allow vials to reach room temperature. This may take up to 60 minutes. Do not use heating devices including microwave. • Do not heat up or shake HyQvia. • Check each vial of HyQvia before using: • Expiration date: Do not use beyond expiration date. • • The recombinant human hyaluronidase should be clear and colourless. • The human normal immunoglobulin 10% can be clear and colourless to pale yellow. • If either liquid is cloudy or has particles, do not use. • Do not use the product if it does not have the cap.
2. Gather all supplies: Dual vial unit(s) of HyQvia, infusion supplies (subcutaneous needle set, solution container (bag or syringe), sterile clear bandage and tape, pump tubing, transfer devices, syringes, gauze and tape), sharps container, pump, and treatment logbook and other supplies as needed. Prepare the pump: program the infusion pump according to prescribed infusion rates and manufacturer's instructions
		3. Prepare a clean work area.
		4. Wash hands: Wash your hands thoroughly. Place all gathered supplies and open them as directed by your healthcare professional.
		5. Open HyQvia dual vial unit(s): Remove purple protective caps to expose the vial stoppers. Prepare to transfer the recombinant human hyaluronidase component of HyQvia by wiping each vial stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds).

6. Prepare recombinant human hyaluronidase vial (HY): Remove the smaller sterile syringe from package and attach to a non-vented spike or needle (device). Pull back on the plunger, fill the smaller syringe with air equal to the amount of in the recombinant human hyaluronidase, labeled with the letters ‘HY’. Remove the cap of needle/non-vented transfer device. Insert the tip of the needle/non-vented transfer device into the center of the vial stopper and push straight downward. Push the air into the vial. Turn the vial upside down, with the needle/non-vented transfer device remaining in the vial. The syringe tip will be pointing upward. Withdraw the full contents of the recombinant human hyaluronidase into the syringe. Repeat above steps, if more than one vial of recombinant human hyaluronidase is needed for your dose. If possible, combine all of the recombinant human hyaluronidase needed for the entire dose of IgG into the same syringe. Point the syringe tip up and remove any air bubbles by pointing the syringe tip up and gently tapping the syringe with your finger. Slowly and carefully push the plunger to remove any remaining air.
7. Prepare the needle set with the recombinant human hyaluronidase (HY): Attach the syringe filled with recombinant human hyaluronidase to the needle set Push the plunger of smaller syringe to remove the air and fill the needle set up to the needle wings with the recombinant human hyaluronidase. Note: Your healthcare professional may recommend using a “Y” connector (for more than one site) or other needle set configuration.
8. Prepare human normal immunoglobulin 10% vial (IG): Prepare to transfer the immunoglobulin 10% component of HyQvia vial(s), labeled with the letters ‘IG’, by wiping the vial(s) stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds). The human normal immunoglobulin 10% of HyQvia may be infused either by pooling from the vials either into (a) larger	a) b)

9. Prepare the infusion site: Choose an infusion site(s) in either the middle to upper abdomen at least 10 cm apart or thigh. See image for infusion site locations. Select sites on the opposite sides of the body if instructed to infuse in two or three sites. Do not infuse more than 600 mL in each site if you weigh 40 kg or more. Do not infuse more than 300 mL in each site if you weigh less than 40 kg. You may have to infuse smaller amounts if you cannot tolerate those infusion volumes. Talk to your doctor. Avoid bony areas, visible blood vessels, scars and any areas of inflammation or infection. Rotate infusion sites by choosing opposite sides of the body between future infusions. As instructed by your health care professional, clean the infusion site(s) with an alcohol swab. Allow to dry (at least 30 seconds).

10. Insert the needle: Remove the needle cover. Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers. Insert needle completely to the wings of the needle with a rapid motion straight into the skin at a 90-degree angle. Wings of needle should lay flat on the skin. Secure needle in place with sterile tape. Repeat this step if you have a second infusion site.

11. Check for proper needle placement before starting the infusion if instructed by your healthcare professional.
12. Secure the needle to the skin: Secure the needle(s) in place by putting a sterile clear bandage over the needle. Check infusion site(s) occasionally throughout the infusion for dislodgement or leaking. Ask your doctor about the needle size appropriate for you. Any change of needle size would have to be supervised by your doctor.
13. Administer the recombinant human hyaluronidase infusion first: Slowly push the plunger of the smaller syringe with the recombinant human hyaluronidase at an initial rate per infusion site to approximately 1 to 2 mL per minute and increase as tolerated. If using a pump, prepare the pump to infuse the recombinant human hyaluronidase at an initial rate per infusion site of 60 to 120 mL/hour and increase as tolerated.
14. Administer the human normal immunoglobulin 10%: • After infusing all of the content of the smaller syringe (recombinant human hyaluronidase), remove the syringe from the hub of the needle set. • Attach the pump tubing or, the larger syringe containing human normal immunoglobulin 10% to the needle set. Administer the human normal immunoglobulin 10% with a pump at the rates prescribed by your healthcare professional and start the infusion. It is very important to infuse the medicine at the correct speed.
15. Flush the pump tubing when the infusion is complete if instructed by your healthcare professional: If instructed by your healthcare professional, attach a saline bag to the pump tubing/needle set to push the human normal immunoglobulin 10% up to the needle wings.
Remove needle set: Remove the needle set by loosening the dressing on all edges. Pull the needle wings straight up and out. Gently press a small piece of gauze over the needle site and cover with a protective dressing. Throw away the needle(s) into the sharps container. Dispose of the sharps container using instructions provided with the container, or contact your healthcare professional.

If you want more information about HyQvia:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (https://www.takeda.com/en-ca), or by calling 1-800-268-2772.

Takeda Canada Inc.

22 Adelaide Street West, Suite 3800

Toronto, ON M5H 4E3

Last Revised:

HyQvia® is a registered trademark of Baxalta Incorporated.

TAKEDA® and the TAKEDA Logo® are trademarks of Takeda Pharmaceutical Company Limited, used under license.